BEUDAMED
    27 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 14, 2024

    Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·December 13, 2023

    ARIES SARS-CoV-2 Assay

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 24, 2022

    Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·July 14, 2021

    Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·July 14, 2021

    Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·July 14, 2021

    Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·July 14, 2021

    Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·July 14, 2021

    Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·July 14, 2021

    Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·August 21, 2019

    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·October 14, 2020

    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·May 25, 2022

    Verigene CDF Nucleic Acid Test, Part No. 30-002-22

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·July 13, 2022

    VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·July 5, 2023